Cleared Traditional

K931422 - DELTATRAC(TM) II METABOLIC MONITOR

K931422 is an FDA 510(k) clearance for DELTATRAC(TM) II METABOLIC MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K931422 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Nov 1993
Decision
247d
Days
Class 2
Risk

K931422 is an FDA 510(k) clearance for the DELTATRAC(TM) II METABOLIC MONITOR. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on November 24, 1993 after a review of 247 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K931422

510(k) Number K931422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date November 24, 1993
Days to Decision 247 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 140d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZL Computer, Oxygen-uptake

All 13
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K931422.
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ERGO-PNEUMOTEST
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